Human
Genetics Alert (1) today criticised the Wellcome Trust and Medical
Research Council's decision to fund BioBank UK as premature.A workshop on ethical issues
held last Thursday showed that crucial ethical foundations of the
study are still being decided, and the Human Genetics Commission has
not been properly consulted. Yet in January, the Health Secretary,
Alan Milburn, pledged that the study would not be given the go ahead
until the ethical issues had been fully addressed (2).

HGA
Coordinator, Dr David King, said: "Unless the ethics are sorted out
before the study is agreed, they are building a house of cards.They seem to think that
ethics is just window dressing.There has been no serious
public consultation or Parliamentary debate on this project.After the Alder Hey scandal
and the GM food fiasco, they should have learned that this kind of
arrogance is no longer acceptable."

·The
risk of breaches of confidentiality:
although the funders insist that patients' medical data and samples
will be held securely, the Information Commissioner has admitted
that the Data Protection Act may fail to protect donors against
'inappropriate disclosure' from the BioBank (3).HGA calls for clear
legislation to protect medical privacy and prevent genetic
discrimination; the current lack of such legislation means that
there is little redress for individuals if leaks do occur.In fact, the government is
currently seeking to make it easier for researchers and NHS staff to
access patients' medical data without their consent, using
regulations under section 60 the Health and Social Care Act
(4).

·The
relationship between BioBank UK and industry:
the proposals lack any clear regime to govern access to patients'
samples by industry.Such a regime would specify what type of research industry
can do, rules preventing doctors' conflict of interest, and how the
NHS will be compensated.The MRC appears ready to let its own scientists, and
companies using the Biobank, patent genes derived from patients'
samples, yet is unwilling to inform patients that this may
happen.HGA calls for a
clear ban on the patenting of genes discovered through the
BioBank.

·Consent:
The project documents show that the funders view sample donors
merely as useful sources of DNA, rather than as real participants in
the project.There are
no clear guidelines, preventing, for example, research in
behavioural genetics or on other non-disease characteristics, which
as recent articles in the British Medical Journal have shown (5), is
a major focus of research for pharmaceutical companies.Instead, the MRC and
Wellcome Trust will require sample donors to give unconditional
consent for the use of their samples, and do not plan to ask donors
for fresh consent in the future if new, unforeseen research is
proposed.

For
further information, contact Dr David King: 020 7704
6100.

Notes
for editors

1.Human Genetics Alert is an
independent watchdog group, funded by a leading British
charity.

2.Speech given by Rt Hon Alan
Milburn MP at international conference 'Genetics and Health - a
Decade of Opportunity',16 January 2002.

3.Information Commissioner's
submission to Human Genetics Commission, cited in HGC 'Comments to
inform the Government response to the House of Lords report on
Genetic Databases', June 13th 2001.

4.Draft regulations can be
found at http://www.doh.gov.uk/ipu/confiden/index15.htm.